Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502801
Status:
COMPLETED
Last Update Posted:
2013-09-25
First Post:
2007-07-16
Brief Title:
An Effectiveness Safety and Microbiology Study of Doripenem in Patients With Nosocomial Hospital-acquired Pneumonia
Sponsor:
PriCara Unit of Ortho-McNeil Inc
Organization:
PriCara Unit of Ortho-McNeil Inc
Study Overview
Official Title:
A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial hospital-acquired pneumonia
Detailed Description:
Nosocomial pneumonia NP accounts for approximately 15 of all hospital-acquired infections The incidence of NP rises in patients who are on breathing machines The death rate for NP can be as high as 30 NP caused by bacteria such as Pseudomonas aeruginosa has been associated with an increased death rate compared to other pathogens Prompt use of appropriate antibiotics is essential Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection The duration of treatment can be anywhere from 8 to 14 days Safety evaluations such as vital signs and laboratory tests will be performed upon enrollment after 4 days on therapy after 9 days on therapy for those on greater than 8 days at the end of therapy 7 to 14 days after the end of therapy and 28 to 35 days after the end of therapy Adverse events will be collected throughout the study Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy Doripenem IV will be administered for a duration of treatment from 8 to 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DORIINI2002 | OTHER | PriCara Unit of Ortho-McNeil Inc | None |